Objective: To discuss the limitations of using the predicted value of Horwitz equation to judge whether the analysis method meets the intended use. Methods: On the basis of introducing the content of the Horwitz equation,the limitations of using the Horwitz equation as accepetance criteria of method validation were analyzed from different points by searching and collecting a large number of domestic and foreign relevant literatures. Results: （1） The predicted value of Horwitz equation did not contain all the method variables; （2） The Horwitz equation did not allow using the uncertainty to evaluate the method performance;（3） The Horwitz equation was not related to product's limits or ranges. Conclusion: Using Horwitz equation as the judging criteria is not reasonable,it should be depended on the total variability of method. The predictive interval,tolerance interval and method capability index were introduced to determine if the method meets the intended use.
MA Li, LI Na, TAN De-jiang, GENG Ying, YANG Hua-xin, HANG Tai-jun, ZHANG Qing-sheng
. Discussion on the limitations of Horwitz equation as an acceptance criteria for method validation*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(4)
: 681
-684
.
DOI: 10.16155/j.0254-1793.2021.04.15
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